Licence application forms

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This section provides downloadable licence application forms for medicines

Portal
The application forms that appear on this page cannot be used for electronic submissions through the MHRA Portal.

Companies registered on the Portal, should obtain application forms from the Portal eSubmission Workspace. Applications outside the remit of the Portal may be submitted using the relevant form below on CD/DVD or paper.  See application types acceptable via eSubmissions on the MHRA Portal.

If you have any problems downloading the forms, please use our technical feedback form.

Clinical trials

Please use the application forms on EudraCT on the European Medicines Agency (EMEA) website (please use link under 'Related information' at the right of this page).

Drug-device combinations forms
Drug-device consultation form (NBA 201) (54Kb)
Export certificate forms
Certificate of pharmaceutical product (licensed products) (76Kb)
Certificate of pharmaceutical product (licensed products) - guidance notes for completion of application form (20Kb)
Certificate of pharmaceutical product (unlicensed products) (84Kb)
Certificate of pharmaceutical product (unlicensed products) - guidance notes for completion of application form (13Kb)
Certificate of manufacturing status (30Kb)
Certificate of manufacturing status - guidance notes for completion of application form (7Kb)
Statement of licensing status of pharmaceutical product(s) (37Kb)
Statement of licensing status of pharmaceutical products - guidance notes for completion of application form (7Kb)
Certificate for the importation of a pharmaceutical constituent (25Kb)
Guidance Notes for the completion of application form for export certification for the importation of a pharmaceutical constituent (57Kb)
Herbal and homoeopathic products
Herbal or homoeopathic registration application form (375Kb)
Registration certificate for a homoeopathic product application form (78Kb)
Import of unlicensed medicinal products
Notification of intention to import (321Kb)
Labelling and leaflet forms
Application for changes to labels and patient information leaflets (36Kb)
Notification of change to labels and leaflets for self certification (128Kb)
Manufacturer's licence forms
Manufacturer’s / importer’s authorisation (ManA) application form (799Kb) (Veterinary Products)
Manufacturer’s / importer’s licence (MIA) application form (797Kb) (Human Products)
Manufacturer "Specials" licence (MS) application form (681Kb) (Human Products)
Manufacturer "Specials" authorisation (ManSA) application form (679Kb) (Veterinary Products)
Manufacturer's authorisation for investigational medicinal products (MIA(IMP)) (770Kb)  (Human Products)
Marketing authorisation application forms
Marketing authorisation application form (542Kb)
Marketing authorisation - application for renewal (159Kb)
Marketing authorisation - application for variation (531Kb)
Marketing authorisation - application for change of ownership (MLA 201 (COA)) (42Kb)
Marketing authorisation - parallel importing (54Kb)
Marketing authorisation - parallel importing (variation) (51Kb)
Sample for a product licence appliation (98Kb)
NSAID Diclofenac Variation Form (113Kb)
NSAID Ibuprofen Variation Form (112Kb)
NSAID Naproxen Form (107Kb)
NSAID Others Variation Form (113Kb)
Non-orthodox practitioners
Non-orthodox practitioner application form (32Kb)
Guidance notes on manufacturer's licences authorising a non-orthodox practitioner to mix and assemble unlicensed (72Kb)
Periodic Safety Update Report submissions
Template for Periodic Safety Update Report (PSUR) submission (22Kb)
Submission of Periodic Safety Update Reports - revised procedure
SmPC template
SmPC template (33Kb)
SmPC fragments
SmPC section 1 - Product name (19Kb)
SmPC section 2 - Qualitative and quantitative composition (19Kb)
SmPC section 3 - Pharmaceutical form (19Kb)
SmPC section 4.1 - Therapeutic indications (19Kb)
SmPC section 4.2 - Posology and administration (19Kb)
SmPC section 4.3 - Contra-indications (19Kb)
SmPC section 4.4 - Special warnings and precautions (19Kb)
SmPC section 4.5 - Interaction (19Kb)
SmPC section 4.6 - Pregnancy and lactation (19Kb)
SmPC section 4.7 - Driving and use machines (19Kb)
SmPC section 4.8 - Undesirable effects (19Kb)
SmPC section 4.9 - Overdose, emergency and antidotes (19Kb)
SmPC section 5.1 - Pharmacodynamics (19Kb)
SmPC section 5.2 - Pharmacokintetics (19Kb)
SmPC section 5.3 - Preclinical safety (19Kb)
SmPC section 6.1 - Excipients (19Kb)
SmPC section 6.2 - Incompatibilities (19Kb)
SmPC section 6.3 - Shelf life (19Kb)
SmPC section 6.4 - Special precautions (19Kb)
SmPC section 6.5 - Container (19Kb)
SmPC section 6.6 - Disposal (19Kb)
SmPC section 7 - MA holder (19Kb)
SmPC section 8 - MA number (19Kb)
SmPC section 9 - Date of the first authorisation or renewal (19Kb)
SmPC section 10 - Date of revision of the text (19Kb)
SmPC section 11 - Dosimetry (19Kb)
SmPC section 12 - Radiopharmaceuticals (19Kb)
Wholesaler Dealer's licence application forms
Wholesale Dealer’s licence (WL) application form (488Kb) (Human Products)
Wholesale Dealer's (General Sales List) application form (454Kb) (Human Products)
Additional requirements - Applicants for new Wholesale Dealer's licences for human use (130Kb) (Human Products)
Additional requirements - Additional Responsible Persons (RPs) to be added to existing Wholesale Dealer's licences (127Kb) (Human Products)
Wholesale Dealer’s authorisation (WDA) application form (481Kb) (Veterinary Products)
Additional requirements - Applicants for new Wholesale Dealer's authorisations (131Kb) (Veterinary Products)
Additional requirements - Additional Wholesale Dealer's Qualified Persons to be added to existing Wholesale Dealer's licences (128Kb) (Veterinary Products)



Page last modified: 01 September 2005